U.S. patent number 6,228,073 [Application Number 09/211,821] was granted by the patent office on 2001-05-08 for angiography luer hub having wings proximal to the plurality of grips and strain relief.
This patent grant is currently assigned to Medtronic, Inc.. Invention is credited to Bruce Adams, Cheryl Fay-Lauria, Michael S. Noone.
United States Patent |
6,228,073 |
Noone , et al. |
May 8, 2001 |
Angiography luer hub having wings proximal to the plurality of
grips and strain relief
Abstract
A hub for connecting a medical catheter in fluid communication
with a medical device, such as a syringe, includes a tubular shaped
body member which has an outer surface that is formed with a
plurality of grips. The hub also has a pair or diametrically
opposed wings which extend from the outer surface of the body
member and it has a proximal end which is formed as a female luer
fitting for engagement with the medical device. The distal end of
the hub is formed with a spiral strain relief element having a
passageway which receives the proximal end of the medical catheter.
In operation, the spiral relief element supports the medical
catheter and prevents kinking of the catheter near the hub during
flexure of the catheter by providing for a progressive transition
from the relative rigidity of the hub to the flexure required by
the catheter.
Inventors: |
Noone; Michael S. (Londonderry,
NH), Fay-Lauria; Cheryl (Burlingtion, MA), Adams;
Bruce (Malden, MA) |
Assignee: |
Medtronic, Inc. (Minneapolis,
MN)
|
Family
ID: |
22788488 |
Appl.
No.: |
09/211,821 |
Filed: |
December 15, 1998 |
Current U.S.
Class: |
604/533; 128/912;
604/177; 604/525; 604/905 |
Current CPC
Class: |
A61M
25/0014 (20130101); A61M 5/007 (20130101); A61M
25/0612 (20130101); A61M 2025/0098 (20130101); Y10S
604/905 (20130101); Y10S 128/912 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/06 (20060101); A61M
5/00 (20060101); A61M 025/00 () |
Field of
Search: |
;604/164,171,177,264,523,525,533,534,905
;128/DIG.26,DIG.6,912,164.01,174 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0 168289 |
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Jan 1986 |
|
EP |
|
0 366336 |
|
May 1990 |
|
EP |
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0 554841 |
|
Aug 1993 |
|
EP |
|
Other References
Mar. 1994 USCI Product Catalog and Price List, p. 5-22. .
Two photographs (one color and one black and white) of SciMed
Maxxum Manifold; the date and origination of this reference is
unknown. The existence of this reference prior to the application
filing date of Dec. 15, 1998, is acknowledged. A prototype will be
furnished upon request. .
Photograph Of SciMed ST 55 CM Guiding Catheter (806 E01777);. The
existence of this reference prior to the application filing date of
Dec. 15, 1998, is acknowledged. A prototype will be furnished upon
request. .
Marketing literature for the SciMed Maxxum, PTCA Dilation Catheter,
Instructions for Use, 6 pages, (81/2.times.11) dated Aug.,
1996..
|
Primary Examiner: Seidel; Richard K.
Assistant Examiner: Thanh; L.
Attorney, Agent or Firm: Sterne, Kessler, Goldstein &
Fox, P.L.L.C.
Claims
What is claimed is:
1. A connector hub attached in fluid communication with a medical
catheter which comprises:
a substantially tubular shaped body member having a proximal end
and a distal end and defining a longitudinal axis, said body member
being formed with a bore extending longitudinally therethrough and
having an outer surface formed with a plurality of grips;
a pair of diametrically opposed planar wings mounted on said body
member, wherein said wings are substantially displaced along said
longitudinal axis from said plurality of grips;
a fitting formed with a fluid channel, said fitting extending from
said proximal end of said body element to join said fluid channel
in fluid communication with said bore; and
a strain relief element formed with a plurality of segmented turns,
said strain relief element extending from said distal end of said
body member, wherein said medical catheter is in fluid
communication with said distal end of said body member.
2. A hub as recited in claim 1 wherein said strain relief element
includes between nine and twenty turns per inch, and wherein each
turn includes a primary segment and a secondary segment with said
secondary segment axially offset from said primary segment, and
wherein said turns are interconnected with each other by attachment
of a primary segment of one turn to a secondary segment of another
turn.
3. A hub as recited in claim 1 wherein said strain relief element
forms a passageway for receiving a portion of said medical catheter
therein.
4. A hub as recited in claim 1 wherein said fitting is a female
luer connector.
5. A hub as recited in claim 1 wherein said grips are a plurality
of depressions formed into said outer surface of said body
member.
6. A hub as recited in claim 1 wherein said grips are a plurality
of ridges formed into said outer surface of said body member.
7. A hub as recited in claim 1 wherein each said wing has a distal
leading edge and a proximal trailing edge with said leading edge
being oriented at an angle to said axis to widen said wing in a
distal to proximal direction and said trailing edge being a convex
curve to transition between said body member and said leading
edge.
8. A medical catheter system engageable in fluid communications
with a medical device, said catheter system comprising:
a substantially tubular medical catheter formed with a lumen and
having a proximal end and a distal end; and
an elongated connector hub unit having a distal end formed for
connection in fluid communication with said medical catheter and a
proximal end formed for connection in fluid communication with said
medical device, said hub unit being formed with a bore extending
longitudinally therethrough for fluid communication between said
distal end and said proximal end, said hub unit having an outer
surface formed with a plurality of grips and formed with a pair of
planar wings extending outwardly from said outer surface, said hub
unit being further formed with a strain relief element formed with
a plurality of segmented turns, wherein each turn includes a
primary segment and a secondary segment with said secondary segment
axially offset from said primary segment, and wherein said turns
are interconnected with each other by attachment of said primary
segment of one turn to said secondary segment of another turn, said
strain relief element extending, distally from said distal end of
said hub unit.
9. A system as recited in claim 8 wherein said grips are a
plurality of depressions formed into said outer surface of said
body member.
10. A system as recited in claim 8 wherein said grips are a
plurality of ridges formed into said outer surface of said body
member.
11. A system as recited in claim 8 wherein said spiral shaped
strain relief element includes between nine and twenty turns per
inch.
12. A system as recited in claim 8 wherein each said wing has a
distal leading edge and a proximal trailing edge with said leading
edge being oriented at an angle to said axis to widen said wing in
a distal to proximal direction and said trailing edge being a
convex curve to transition between said body portion and said
leading edge.
13. An integrally molded catheter hub comprising:
a tubular body having a proximal end, a distal end, an outer
surface, and a bore extending longitudinally therethrough;
a female catheter fitting forming the proximal end of the body;
a pair of diametrically opposed planar wings formed on the body at
a location distal of said fitting;
a strain relief forming the distal end of the body, the strain
relief having a plurality of longitudinally spaced turns that taper
distally; and
a slip resistant surface formed on the outer surface of the body at
a location distal of said wings.
14. A catheter hub according to claim 13 wherein said slip
resistant surface comprises a plurality of grips.
15. A catheter hub according to claim 13 wherein said
longitudinally spaced turns are segmented turns, each turn
including a primary segment and a secondary segment with the
secondary segment axially offset from the primary segment, and
wherein said turns are interconnected with each other by attachment
of the primary segment of one turn to the secondary segment of
another turn.
Description
FIELD OF THE INVENTION
The present invention pertains generally to connector hubs for
medical catheters. More particularly, the present invention
pertains to connector hubs which are used to establish fluid
communication between an interventional medical catheter and an
extracorporeal medical device. The present invention is
particularly, but not exclusively, useful for providing tactile
control for a physician during the positioning and use of the
medical catheter during a clinical procedure.
BACKGROUND OF THE INVENTION
The general purpose of a luer hub is to connect a catheter to some
mating piece of equipment such as a syringe, a power injection tube
or a manifold. It happens, however, that the luer hub is also used
by physicians to control the positioning of the catheter as it is
being advanced into the vasculature of a patient. In order for the
physician to properly control the catheter during such an
advancement, it is necessary to subject the catheter to both axial
and rotational forces. A major concern in all of this is that,
while the forces which are exerted on the catheter must provide for
the desired degree of catheter flexibility and operational control,
they can not be allowed to cause the catheter to kink or otherwise
become inoperative.
Various types of connecting hubs have been proposed for specialized
uses with various types of catheters. For example, U.S. Pat. No.
4,445,893, which issued to Bodicky for an invention entitled
"Infusion Apparatus," discloses an intravenous catheter placement
device which includes a hub that is attached directly to a rigid
cannula. In another example, U.S. Pat. No. 4,875,481, which issued
to Higgins for an invention entitled "Catheter with Coiled Wire
Attachment," discloses a wire having a coiled proximal end that is
positioned in a hub, and an elongated distal end which extends from
the hub through the PTCA catheter. The wire in this case is used
for steering control over the catheter by rotation of the hub. In
yet another example, U.S. Pat. No. 5,167,647, which issued to
Wijkamp et al. for an invention entitled "Catheter with a Strain
Relief Member," discloses a tubular shaped strain relief member
which extends distally from the hub and over a short portion of the
catheter. None of these examples, however, teach or suggest a hub
and strain relief element which are formed, in combination, as an
integral unit, and which provide for a progressive transition from
the relative rigidity of the hub to the flexure required by the
associated catheter. More recently, however, efforts have been made
to address this issue. For example, U.S. application Ser. No.
09/021,682, and U.S. application Ser. No. 09/046,241, which are
each assigned to the same assignee as the present invention, both
disclose spiral strain relief elements which are designed to
provide such a transition, albeit with different structure than
disclosed herein for the present invention.
An angiographic catheter, due to the nature of its specific
function, can be designed to have a relatively small diameter.
Hence, in comparison with infusion catheters, such as PTCA
catheters and atherectomy catheters which often require relatively
large diameters, the angiographic catheter and other small diameter
catheters are particularly susceptible to kinking. It often happens
that this problem is most pronounced near the hub where control
forces are imparted by the physician to control movement of the
catheter into a patients vasculature.
In light of the above, it is an object of the present invention to
provide a connector hub which provides the physician with control
and sensitivity during the placement of a catheter into the
vasculature of a patient. It is another object of the present
invention to provide a connector hub for a catheter which will
provide for a progressive transition from the relative rigidity of
the hub to the flexure required by the catheter. Yet another object
of the present invention is to provide a connector hub for a
catheter which presents the hub and a strain relief element as an
integral unit. Another object of the present invention is to
provide a connector hub for a catheter which is ergonomically
efficient in providing a physician with control structure for
rotating and advancing the catheter into the vasculature of a
patient. Still another object of the present invention is to
provide a connector hub for a catheter which is easy to
manufacture, relatively simple to use and comparatively cost
effective.
SUMMARY OF THE PREFERRED EMBODIMENTS
A luer connecting hub for interconnecting a catheter in fluid
communication with a piece of medical equipment includes a
substantially tubular shaped body member which is formed with a
bore that extends longitudinally through the body member. The outer
surface of the body member is formed with a plurality of
longitudinally oriented grips, and proximal to the grips there are
a pair of diametrically opposed wings, or lobes, which extend
outwardly from the body member. The proximal end of the body member
is formed as a female luer fitting for engaging a medical device,
such as a syringe or a manifold, in fluid communication with the
bore of the body member.
Extending from the distal end of the connecting hub is an integral
strain relief element which is formed as an articulated spiral
having a plurality of segmented turns. More specifically, the
spiral shaped strain relief element establishes a passageway for
receiving a catheter tube therethrough. Thus, when the proximal end
of the catheter tube is connected to the distal end of the bore,
through the body member of the hub, the spiral shaped strain relief
element will surround and support a proximal portion of the
catheter tube.
With this combination of structure, the spiral strain relief
element is able to bend in a controlled manner to provide a
progressive transition from the relative stiffness imposed by the
hub on the catheter tube to the full flexure capability of the
catheter tube. Importantly, this progressive transition avoids
unwanted and undesirable kinking in the proximal portion of the
catheter tube near the luer hub.
BRIEF DESCRIPTION OF THE DRAWINGS
The novel features of this invention, as well as the invention
itself, both as to its structure and its operation, will be best
understood from the accompanying drawings, taken in conjunction
with the accompanying description, in which similar reference
characters refer to similar parts, and in which:
FIG. 1 is a perspective view of the connector hub of the present
invention shown connected with a catheter tube and positioned for
engagement with a medical device;
FIG. 2 is a perspective view of the connector hub;
FIG. 3A is a cross sectional view of the connector hub as seen
along the line 3--3 in FIG. 2; and
FIG. 3B is a cross sectional view of the connector hub as seen in
FIG. 3A with a catheter tube attached to the connector hub.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring initially to FIG. 1, a luer connector hub in accordance
with the present invention is shown in its operational environment
and generally designated 10. As intended for the hub 10 of the
present invention, it is to be used to interconnect a catheter tube
12 (shown attached to the distal end of the hub 10) in fluid
communication with a medical device 14 (shown positioned for
attachment to the proximal end of the hub 10). More specifically,
the catheter tube 12 of particular interest for the present
invention is one that is suitable for use as an angiography
catheter or a guide catheter. Consequently, the catheter tube 12
will be fairly flexible and have a relatively small diameter.
Specifically, the catheter tube 12 will typically be made of a
plastic material, such as polyurethane, and will have an outside
diameter which will be in the range of from four to seven french
(4-7F). Not so specifically, the medical device 14 can be of any
type well known in the pertinent art. For instance, the medical
device 14 can include equipment such as the syringe (shown in FIG.
1), power injection tubes (not shown) or manifolds (not shown).
In FIG. 1 it will be seen that the luer connector hub 10 of the
present invention is an integral unit which includes three
interconnected elements. These elements are: a spiral strain relief
element 16 at the distal end of the hub 10, a female luer fitting
18 at the proximal end of the hub 10, and a body member 20 which is
intermediate the spiral strain relief element 16 and luer fitting
18. The specific external features of the connector hub 10 can,
perhaps, best be seen with reference to FIG. 2.
FIG. 2 shows that the outer surface 22 of the connector hub 10 is
formed with a plurality of grips which are manifest as
longitudinally oriented parallel depressions 24. Between these
depressions 24 are an equal number of longitudinally oriented
parallel ridges 26. Collectively these depressions 24 and ridges 26
combine to create flutes which provide a slip resistant surface
that can be used by the physician to rotate the hub 10, and
accordingly, the catheter tube 12. The longitudinal length of the
depressions 24 and ridges 26 are generally a matter of design
choice and can be selected to give the physician the best tactile
sensitivity. Further, and perhaps more importantly, the length of
the depressions 24 and ridges 26 (flutes) are sufficient to allow a
physician to effectively rotate the hub 10 between a thumb and
forefinger.
FIG. 2 also shows that the outer surface 22 of the body member 20
of luer connector hub 10 is formed with a pair of diametrically
opposed wings 28a and 28b. As shown, each of the wings 28a,b has a
leading edge 30 which is generally straight and inclined with the
longitudinal axis of the luer connector hub 10 through an angle
.alpha.. For the present invention, the angle .alpha. will be in
the range of 25.degree. to 45.degree., and will preferably be about
35.degree.. Each of the wings 28a,b also has a generally arcuate
trailing edge 32 which is convex and which transitions between the
outer surface 22 of body member 20 and the leading edge 30. With
this geometry, the wings 28a,b present a heart-shaped structure
which can be used by the physician to control the angular position
of the hub 10 and the torsional forces that are applied to the
catheter tube 12. The exact dimensions of the wings 28a,b are
somewhat a matter of design choice, but should be chosen to give
the physician optimal control.
Still referring to FIG. 2, it will be seen that additional external
features of the luer connector hub 10 of the present invention
include a thread 34 which is formed onto the luer fitting 18. The
purpose of thread 34 is facilitate a fluid tight connection between
the luer connector hub 10 and the medical device 14. Additionally,
it is seen in FIG. 2 that the spiral strain relief element 16
comprises a plurality of longitudinally spaced turns 36. These
turns 36 are integrally contiguous and, together, create a
generally helix shaped structure which forms the spiral strain
relief element 16. More specifically, as perhaps best appreciated
by cross referencing FIG. 2 and FIG. 3A, each of the turns 36 in
strain relief element 16 is segmented and includes both a primary
segment 37' and a secondary segment 37". As shown, the primary
segments 37' are axially off-set from the secondary segments 37"
and are generally oriented in planes that are perpendicular to the
longitudinal axis of the hub 10. As also shown, along the strain
relief element 16 the primary segment 37' of one turn 36 is
directly interconnected with the secondary segment 37" of an
adjacent turn 36, and vice versa, i.e. the secondary segment 37" of
one turn 36 is directly interconnected with the primary segment 37'
of an adjacent turn 36. This specific structure for the strain
relief element 16 is particularly well suited for manufacture by
injection molding. For purposes of the present invention, the
spiral strain relief element 16 will contain between nine and
twenty turns 36 per inch. The internal structural features of the
luer connector hub 10 of the present invention are, perhaps, best
seen in FIG. 3A.
In FIG. 3A it will be seen that the body member 20 of luer
connector hub 10 is formed with a bore 38 which extends
longitudinally along the entire length of the body member 20.
Further, it will be seen that luer fitting 18 is 30 formed with a
fluid channel 39 which is in fluid communication with the bore 38.
Additionally, it will be seen that the turns 36 of spiral strain
relief element 16 form a passageway 40, and that there is a cavity
42 formed at the distal end of the body member 20 which is in fluid
communication with the bore 38. It is to be appreciated that the
entire connector hub 10 can be manufactured as an integral unit by
any means well known in the pertinent art, such as injection
molding.
In the assembly of luer connector hub 10 of the present invention
with the catheter tube 12, as best seen in FIG. 3B, the proximal
end of the catheter tube 12 is inserted through the passageway 40
of spiral strain relief element 16, and into the cavity 42 of body
member 20. Insertion of the catheter tube 12 continues until the
catheter tube 12 abuts the shoulder 44. With the catheter tube 12
in position on the luer connector hub 10 as shown in FIG. 3B, the
catheter tube 12 is bonded to the connector hub 10 in any manner
well known in the pertinent art, such as by heat bonding or
adhesive bonding. Importantly, the turns 36 of spiral strain relief
element 16 are not bonded to the catheter tube 12. With this
cooperation of structure, the spiral strain relief element 16 is
able to bend with the catheter tube 12 and provide a progressive
transition for bending of the catheter tube 12 as it extends
distally from the luer connector hub 10. Further, the medical
device 14 can be engaged with the fitting 18 of hub 10 and the hub
10 will then be operational.
While the particular Angiography Luer Hub as herein shown and
disclosed in detail is fully capable of obtaining the objects and
providing the advantages herein before stated, it is to be
understood that it is merely illustrative of the presently
preferred embodiments of the invention and that no limitations are
intended to the details of construction or design herein shown
other than as described in the appended claims.
* * * * *